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Non-invasive Detection of Coronary Artery Stenosis

NCT06750016 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-12-27

No results posted yet for this study

Summary

The aim of this viability study is to investigate using a novel medical device, the potential for detecting partial blockages in the arteries within the wall of the heart (coronary artery stenosis). A prototype device will be used in the proposed study. It is a stick-on patch containing sensors which measure the vibration produced at the chest surface by flowing blood as it accelerates through the narrowed artery in the heart emerging downstream, hitting the inner wall of the artery and causing it to vibrate. Some of the energy in the vibrations reaches the skin of the chest, allowing the blockage to be detected non-invasively. The principle has been proved in the laboratory using a simple chest model but to date no measurements have been made in people. Therefore, the proposed trial will serve as the first in-human measurements and will involve a small number of patients and healthy volunteers, with the objective of establishing if it is possible to determine the presence or absence of the stenosis.

The patch will be tested by recording acoustic signatures in healthy volunteers, then in patients undergoing coronary CT angiography. Results will be validated against the CT angiography gold standard. At this early stage no clinical decisions will be made based on the patch recordings and the data will be used only to assess the feasibility of continuing the development of the device.

Conditions

  • Coronary Arterial Disease (CAD)

Sponsors & Collaborators

  • Queen Mary University of London

    collaborator OTHER

  • Nilocas

    lead INDUSTRY

Principal Investigators

  • Francesca Pugliese, MD · Queen Mary University of London

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2025-10-31
Completion
2025-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06750016 on ClinicalTrials.gov